An interventional study of Group A-Paravertebral block and Group B- No block in Post Operative Pain, sponsored by Loyola University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by Loyola University · Not applicable, Interventional, and Treatment
This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.
The strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (ESWL), ureteroscopy, open surgery and percutaneous nephrolithotomy (PCNL). PCNL in an inpatient procedure performed in two steps. Step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. This step is typically performed by interventional radiologists under conscious sedation. Step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. The minimally invasive approach of PCNL is well accepted to be as effective as open procedures for stone removal with less morbidity. Post-operative pain management remains challenging and can lead to extended hospital stays.
This randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 46 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randodmized to this arm will have a local anesthetic injection and pressure applied to the paravertebral space. A paravertebral injection will not be conducted.
Other: Group B- No block
Participants randodmized to this arm will have a local anesthetic (Bupivicaine 0.5% without epinephrine) injection and will be given a paravetebral block into the T10 paravertebral space..
Drug: Group A-Paravertebral block
Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group
Also known as: Group A-Paravertebral block Active Group
direct pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block.
Also known as: Placebo Group
Pain Score
post-operative pain will be measured by the Visual Analog Scale (VAS.
Time frame: 24 hours
Opiod Use
All patients will receive the same post-operative pain control, which does not deviate from our standard protocol for patients receiving PCNL. All patients will be immediately given a PCA in recovery. Patients allergic to morphine/dilaudid will be given a narcoticopioid substitute (that will be converted to morphine equivalents for the purpose of the study). Nurses will be allowed to administer IV boluses of morphine PRN for inadequate pain control. If four boluses did not yield adequate analgesia, fentayl 50mcg will be used until adequate pain control is achieved.
Time frame: 24 hours
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Loyola University